Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME)

  • STATUS
    Recruiting
  • End date
    Jan 9, 2024
  • participants needed
    100
  • sponsor
    Rezolute
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Updated on 9 April 2023
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Summary

The objective of this trial is to assess the safety, efficacy, and tolerability of RZ402 in patients with Diabetic Macular Edema.

Description

Diabetic macular edema (DME) is a common retinal microvascular complication in diabetic patients that can lead to progressive loss of visual acuity and ultimately to complete vision loss. DME is the main cause of vision loss in patients with Type 2 diabetes. There is a significant unmet medical need to develop better therapies of DME and diabetic retinopathy (DR). RZ402 is a potent and selective plasma kallikrein inhibitor (PKI), which is being developed as an oral therapy for the chronic treatment of DME and DR.

This is a Phase 2, Randomized, Double-Masked, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of RZ402 in Participants with Diabetic Macular Edema (DME). A screening period of up to 4 weeks will evaluate eligibility. Once enrolled, patients will be randomized with a 1:1:1:1 ratio to receive RZ402 or placebo for up to 12 weeks. After completing dosing, the patient will enter into a 4 week follow up period.

Details
Condition Diabetic Macular Edema
Treatment Experimental: Group 1, Experimental: Group 2, Experimental: Group 3, Placebo: Group 4
Clinical Study IdentifierNCT05712720
SponsorRezolute
Last Modified on9 April 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

General Inclusion Criteria
Confirmed diabetes mellitus Type 1 or Type 2
Stable glycemic control
Study Eye Inclusion Criteria
Mild to moderate non-proliferative diabetic retinopathy (NPDR) with retinal thickening due to CI-DME as determined by the Investigator
Spectral Domain Optical Coherence Tomography (SD-OCT) foveal CST at screening measuring ≥320 µm (or corresponding values)
Best Corrected Visual Acuity ETDRS letter score at 4 meters of ≤78 letters at screening
Media clarity, pupillary dilation, and participant cooperation sufficient for adequate clinical evaluations, OCT images and fundus photographs, at screening
Fellow Eye Inclusion Criteria
Best Corrected Visual Acuity ETDRS letter score at 4 meters of ≥5 letters at screening

Exclusion Criteria

Study Eye Exclusion Criteria
Received more than 3 anti-VEGF injections (including Avastin) and/or received a recent anti-VEGF injection within 8 weeks of Randomization
Any history of retinal surgery or other surgical intervention for DME
Intraocular surgery (including cataract surgery), within 12 weeks prior to Randomization, or anticipated need for ocular surgery during the study period
History of trabeculectomy or other filtration surgery (prior laser trabeculoplasty and placement of iStent®1 in conjunction with cataract surgery is permitted if the procedure took place ≥12 weeks prior to Randomization)
Autoimmune idiopathic inflammatory eye disease such as anterior uveitis, or participants with history or signs of chronic inflammation
Full thickness macular hole or retinal detachment
Panretinal, macular focal, or grid laser photocoagulation within 16 weeks of Randomization or anticipated need for the use of laser photocoagulation during the study period
Uncontrolled glaucoma, at screening, defined as IOP ≥25 mmHg
The use of corticosteroids as follows
Topical corticosteroids within 12 weeks prior to Randomization and throughout the remainder of the study
Use of intraocular or sub-Tenon's steroids within 2 years of Randomization in phakic eyes or 9 months of Randomization in pseudophakic eyes, and throughout the remainder of the study
Fellow Eye Exclusion Criteria
Intraocular or sub-Tenon's steroid injection within 6 months of Randomization and
throughout the remainder or the study
General Exclusion
Use of the following medications or substances within the specified timeframes below
and throughout the remainder of the study
a. Within 16 weeks of Randomization: i. Systemic anti-VEGF or pro-VEGF treatments ii
Systemic, approved, or off-label drugs or devices used to treat DME iii. Participated
in an investigational drug or device study within 16 weeks or 5 half-lives (whichever
is longer) of Randomization, including systemic or ocular studies iv. Initiation of
drugs or substances known to improve or worsen macular edema e.g., Latanoprost or
phosphodiesterase-5 (PDE-5) inhibitors (e.g., Sildenafil or others in PDE-5 class)
but participants may remain on these drugs if they were initiated >16 weeks prior to
Randomization
b. Within 12 weeks of Randomization: i. Use of tobacco- or nicotine- containing
products (e.g., cigarettes, cigars, chewing tobacco, snuff, vaping)
c. Within 4 weeks of Randomization: i. Anti-coagulants, except for aspirin ≤325 mg/day
and/or clopidogrel ≤75 mg/day (or equivalent drug class) ii. Total daily doses of
Metformin >1000 mg iii. Total daily doses of niacin (Vitamin B3) >1.5 g/day iv. Use of
systemic steroids at supraphysiologic doses (e.g., prednisone equivalent of 5 mg/day
or hydrocortisone equivalent of 20 mg/day)
v. Drugs that may affect the retina or optic nerve such as quinolones, thioridazine
deferoxamine, ethambutol, vigabatrin, and pentosan
Alanine aminotransferase (ALT), or aspartate aminotransferase (AST), or alkaline
phosphatase (ALP) ≥2X upper limit of normal (ULN), total bilirubin ≥1.5X ULN, or
gamma-glutamyl transferase (GGT) ≥3X ULN as per the central laboratory
Estimated glomerular filtration rate (eGFR) at ≤45 mL/min and/or history of persistent
micro or macro albuminuria
History of current or prior (within 1 year of Randomization) any significant illness
or any medical history
History of bariatric surgery or other surgical or medical history
History of current or prior (within 1 year of Randomization) abnormal, clinically
significant ECG including inadequately controlled hypertension
History or evidence of inherited bleeding diathesis or significant coagulopathy at
risk of bleeding
Surgical procedure (including open biopsy, surgical resection, wound revision, or any
other major surgery involving entry into a body cavity) or significant traumatic
injury
Known history of human immune-deficiency virus (HIV), hepatitis C, or hepatitis B
infection
Malignancies within 3 years prior to Randomization
Donated more than 500 mL of blood or significant blood loss within 60 days before
Randomization
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